FDA Establishes April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH)
Comprehensive Data Package Supported by Positive Results from Phase 3 STRIVE-ON Safety Trial of GTx-104 PRINCETON, N.J., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a... Read more
New Drug Application (NDA) for low-dose contrast agent gadoquatrane seeks approval for contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system (CNS) and other body regions for adults and pediatric patients including neonates
Submitted dose corresponds to a 60 percent reduction in gadolinium compared to macrocyclic gadolinium-based contrast agents (GBCAs) dosed at 0.1 mmol gadolinium per kilogram of body weight WHIPPANY, N.J. / Aug 27, 2025 /... Read more
FDA acceptance enables initiation of a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS HOUSTON, Aug. 25, 2025 /PRNewswire/ -- Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announces that the... Read more
SL-325 is a potentially first-in-class DR3 antagonist antibody being developed for the treatment of Inflammatory Bowel Disease (IBD) and other inflammatory and immune-mediated diseases
The Company is on track to dose the first participant in its Phase 1 SL-325 clinical trial in healthy volunteers in Q3 2025
Current cash and cash equivalents, plus the anticipated aggregate proceeds of up to $103 million from recent private placement, assuming full exercise of common... Read more
U.S. Food and Drug Administration accepts sNDA for filing with priority review; sets PDUFA goal date of December 20, 2025
European Medicines Agency accepts and validates submission for Type II variation MAA for setmelanotide to treat acquired hypothalamic obesity
Company to host “Commercial Readiness for Acquired Hypothalamic Obesity,” event for investors and analysts on Wednesday, September 24, in Boston BOSTON, Aug. 20, 2025 (GLOBE NEWSWIRE)... Read more
INDs Transferred from Statera Biopharma Advance Entolimod for ARS Along Regulatory Pathway and Enable Pursuit of Clinical Trial Program in Neutropenia and Lymphocyte Exhaustion FREMONT, Calif. / Aug 20, 2025 / Business Wire / Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, today announced it has received, from Statera Biopharma, two investigational new drug applications (INDs) for its lead candidate, Entolimod™. The two INDs cover... Read more
NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, is pleased to announce that the U.S. Food & Drug Administration (FDA) have approved the IND for its Phase 2a clinical trial of intranasal foralumab in patients with Multiple... Read more
Filing based on pivotal Phase 3 VERITAC-2 clinical trial demonstrating statistically significant and clinically meaningful improvement in median progression-free survival versus fulvestrant
Vepdegestrant is the first PROteolysis TArgeting Chimera (PROTAC) to demonstrate clinical benefit in patients with breast cancer NEW HAVEN, Conn., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today with its partner Pfizer Inc. (NYSE: PFE), announced... Read more
Regulatory filing marks significant milestone for medication designed to provide once-daily, entire active-day symptom control in ADHD patients KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced that it has submitted... Read more
Novel combination therapy with STAR-001 targets the most aggressive and deadliest forms of brain cancer at first progression
GBM represents an annual market opportunity of $3 to $5 billion USD with an accelerating number of cases globally
Lantern Pharma has previously received both FDA Orphan and Fast Track Designations in GBM DALLAS / Aug 06, 2025 / Business Wire / Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma Inc. (NASDAQ: LTRN), today announced... Read more
Designed to expand PSMA PET imaging access for patients by increasing batch size by ~50% and enhancing supply resilience
PDUFA date set for March 6, 2026 BEDFORD, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that the Food and Drug Administration... Read more
CID-103 is a potential best-in-class, anti-CD38 monoclonal antibody; binds to unique CD38 epitope Phase 1 study in adults with active and chronic active renal allograft AMR planned to initiate AMR is a leading cause of kidney transplant loss, leading to dialysis and/or repeat renal transplant SAN FRANCISCO, CA / ACCESS Newswire / August 4, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing... Read more
Progress Follows Positive Immune Response Observed in Phase 1 Study SAN JOSE, Calif., Aug. 4, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that, in collaboration with Cleveland Clinic, it has initiated the transfer of the Investigational New Drug (IND) application that supported the Phase 1 clinical trial of its breast cancer v... Read more
Combination therapy has potential to be an all-oral, fixed-duration regimen for previously untreated patients with CLL
Application is supported by data from the Phase 3 AMPLIFY trial that showed statistically significant improvement in progression-free survival vs chemoimmunotherapy
Regimen offers an opportunity for patients to take time off treatment, an important step toward improved disease management NORTH CHICAGO, Ill., July 29, 2025 /PRNewswire/ -- AbbVie... Read more
Oral, non-opioid drug candidate advancing through Phase 1 and nearing completion of the single ascending dose (SAD) portion as the Company prepares to launch U.S. Phase 2a by year-end MIAMI, FLORIDA / ACCESS Newswire / July 29, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company developing novel therapies for neurologic, neuropsychiatric, and metabolic disorders, today announced that the U.S. Food and Drug Administration (FDA) has... Read more
Second antibody-drug conjugate (ADC) to progress into clinical development utilizing our proprietary payload and optimized antibody
Preclinical results demonstrate strong anti-tumor activity and favorable tolerability profile
Phase 1 clinical trial evaluating ZW251 in hepatocellular carcinoma (HCC) expected to be initiated in 2025 VANCOUVER, British Columbia, July 28, 2025 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing... Read more
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor
Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites
Submission underscores potential to offer moderate-to-severe plaque psoriasis patients the standout combination of complete skin clearance,... Read more
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor
Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites
Submission underscores potential to shift the treatment paradigm for moderate-to-severe plaque psoriasis patients with the standout... Read more
WATERTOWN, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced positive feedback from its pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned NDA submission for bitopertin in EPP.
“At the pre-NDA... Read more
Company focused on obtaining approval for outpatient (at-home) use of IGALMI® for the acute treatment of agitation associated with bipolar disorders or schizophrenia
Pre-Supplemental New Drug Application meeting with FDA scheduled for August 20, 2025 NEW HAVEN, Conn., July 21, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today... Read more
Applications supported by positive results from the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials, in which significantly more patients treated with Sotyktu achieved ACR20 response compared with placebo at Week 16
U.S. Food and Drug Administration assigned a target action date of March 6, 2026 PRINCETON, N.J. / Jul 21, 2025 / Business Wire / Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted... Read more
New Drug Application supported by results from the Phase 2b SunRISe-1 study RARITAN, N.J., July 17, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) granted Priority Review to the New Drug Application (NDA) filed for TAR-200, an intravesical gemcitabine releasing system, for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer... Read more
PDUFA Target Action Date December 16, 2025 LEXINGTON, Mass. / Jul 17, 2025 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease. The FDA assigned a Prescription Drug User Fee... Read more
REDWOOD CITY, Calif. / Jul 14, 2025 / Business Wire / Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant, to treat... Read more
Doravirine/islatravir would be the first FDA-approved two-drug regimen without an integrase inhibitor that demonstrated non-inferior efficacy and a generally comparable safety profile to the three-drug InSTI-based regimen, BIC/FTC/TAF, in a Phase 3 pivotal trial RAHWAY, N.J. / Jul 10, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review... Read more
SGT-501 is a novel gene therapy for rare, life-threatening, genetic arrhythmogenic disease with no approved therapies
SGT-501 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA
Solid expects to initiate Phase 1b clinical trial of SGT-501 in the fourth quarter of 2025
Expands Solid’s clinical pipeline to include first cardiac indication with urgent unmet medical need CHARLESTOWN, Mass., July 08, 2025... Read more
Accepted IND application allows for development program to move directly to a Phase 2 pivotal registration clinical trial
Phase 2 clinical trial initiation anticipated in first half of 2026
Pediatric cardiomyopathies affect at least 100,000 children worldwide
Effective treatment options are limited, with nearly 40% of children with DCM requiring a heart transplant or dying within two years of diagnosis MIAMI, July 08, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc.... Read more
Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo
CAPLYTA® is FDA approved to treat schizophrenia and is the first and only approved treatment for bipolar I and II depression as an adjunctive and monotherapy
With the addition of CAPLYTA® to Johnson & Johnson's robust portfolio of therapies, the Company now offers the broadest range of treatment options for adults... Read more
NDA assigned a Target Action Date of February 25, 2026
Product has patent protection through 2044 DEER PARK, Ill., July 08, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the Company’s New Drug Application (NDA) for ET-600, a proprietary patented formulation of desmopressin oral... Read more
US phase 1 trial of ‘2510 is expected to be initiated before the end of 2025
Anticipate ImmuneOnco sharing initial safety and efficacy results from phase 2 trial of ‘2510 + chemo in 1L NSCLC in the second half of 2025 DALLAS, July 02, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, today announced the clearance of an Investigational New... Read more
